Apparatus and method for laparoscopic urethropexy

ABSTRACT

A suture retrieval tool for use in a laparoscopic urethropexy procedure is provided. The suture retrieval tool comprises a retrieving end and a handle. The retrieving end has a rigid, rod-like shaft and a sharp tip capable of penetrating periurethral tissue, whereby the retrieving end may be inserted into a vagina, through the vaginal mucosa and periurethral tissue adjacent a urethra, and into the space of Retzius, such that the retrieving end may be employed to snare a suture positioned in the space of Retzius for retrieving the suture into the vagina. The suture retrieval tool also preferably comprises a midshaft positioned between the retrieving end and the handle. In order to facilitate snaring of the suture, the retrieving end further comprises a return leg extending from the sharp tip parallel to, and spaced from the rod-like shaft, such that the return leg, the underside of the sharp tip, and the rod-like shaft define a U-shaped region capable of snaring a suture therein when this U-shaped region is pulled over a suture. A surgical method for vaginally retrieving a suture extending from an anchor secured within a bore in the pubic bone of a patient is also provided. This surgical method uses the suture retrieving tool provided herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed towards apparatus and methods for alaparoscopic urethropexy procedure for the correction of female stressurinary incontinence. More particularly, the present invention providesapparatus and methods for performing the urethropexy throughlaparoscopic techniques, thereby greatly reducing the duration,discomfort, and recovery period of such surgeries.

2. Description of Related Art

Female stress urinary incontinence (SUI), defined as the unintentionalloss of urine, can be a socially unacceptable problem for many women.Most often, the incontinence occurs during coughing, sneezing, orphysical activity in women afflicted with this problem. While effectivesurgical treatment for this condition has existed for nearly 50 years,the procedures typically involve major abdominal surgery withaccompanying post-operative limitations lasting six to eight weeks.Because of the nature of these surgical procedures, many women simplyresort to diaper-like incontinence pads, or simply avoid any activitieswhich result in the unintentional loss of urine.

In the normal resting state, the external pressure exerted on thecollapsible urethra by the surrounding musculature is greater than thepressure exerted on the bladder, and therefore continence is maintained.During moments of coughing, sneezing, or physical activities, greaterpressure will be exerted on the dome of a filled bladder. In women notafflicted with stress incontinence, a corresponding increase in theexternal pressure on the urethra acts to prevent the unwanted loss ofurine from the bladder. Sufferers of SUI, however, aren't so fortunate.

Stress incontinence is generally caused by two etiologies: a spasticdetrusor muscle; or a loss of support of the periurethral tissue at theurethrovesicular junction ("UVJ"--the region where the urethra entersthe bladder). When the latter situation occurs, the UVJ will sag intothe vagina, thereby reducing the pressure which can be exerted on theurethra during moments of stress. Diagnosis of any sagging of the UVJcan be easily determined by inserting the tip of a cotton swab into theurethra until it reaches the UVJ. The patient is then asked to bear downas if urinating, and loss of the UVJ support is readily identified bythe upward movement of the wooden end of the cotton swab. In this test,the external urethral meatus acts as a fulcrum for the tip of the swab,and the elevation of the opposite end indicates the downward descent ofthe UVJ. U.S. Pat. No. 4,072,144 provides an alternative device whichmay be utilized to readily measure the angle of the UVJ in a similarmanner.

The first urethropexy procedure for eliminating SUI caused by a saggingurethra was developed in 1948 by Drs. Marshall, Marchetti, and Krantz,and generally involves the fixation of the periurethral tissue at theUVJ on either side of the urethra (MMK procedure). Fixation in the MMKprocedure, also known as urethropexy or abdominal culposuspension, isaccomplished by suturing the periurethral fascia at the UVJ on eitherside of the urethra to the periosteum of the pubic bone. The procedureessentially alters the angular relationship between the urethra andbladder by elevating the UVJ, and therefore preventing the sagging ofthe UVJ when downward pressure is applied to the region by variousstresses.

The MMK procedure has been perfected over the years, however theessential principles have remained the same. In 1955 Burch developed thetechnique of affixing the periurethral fascia bilaterally to Cooper'sligament, thereby resulting in a technically easier procedure because ofthe previous difficulties in passing a needle through the periosteum ofthe pubic bone. Although the Burch procedure has been performedlaparoscopically, the five-year failure rate for the open Burchprocedure is approximately 60%. A laparoscopic Burch procedure is evenmore problematic since it is extremely difficult and time-consuming totie sutures laparoscopically.

Alternatively, urological procedures such as that of Stamey, Raz andPeyerra have been developed, however these are typically blindprocedures which require the passing of long needles through the rectusfascia to the periurethral fascia utilizing a cystoscope. Although theseurological procedures avoid the 10-centimeter midline or Pfannenstielincision and its required three-day or longer hospital stay, thegynecological procedures of MMK, Burch and others have proven to be themost effective. In fact, the scarring of the urethra and interiorbladder as well as the scarring of the periurethral tissues, aids infixation of all of the involved tissues during the MMK and Burchprocedures, thereby assisting in the prevention of incontinence.

Recently, a modified version of the MMK procedure has been developedwhich utilizes bone anchors secured directly to the pubic bone on eitherside of the symphysis for fixation of the UVJ. The apparatus forperforming this modified MMK procedure are sold by Mitek SurgicalProducts, Inc. of Norwood, Mass., and a number of U.S. patents concernthese products (see, e.g., U.S. Pat. Nos. 5,207,679, 5,217,486 and4,899,743). In the Mitek-MMK procedure, a Pfannenstiel incision must bemade in the abdomen in order to provide access to the space of Retzius.The space of Retzius is in actuality a "potential" space in that itcontains various connective tissues and fats which must be dissected inorder to provide sufficient access to this region. In fact, thisconnective tissue, particularly the areolar adventitial tissue,generally breaks down after delivery of a child, and this breaking downof the connective tissue often contributes to the onset of SUI in manywomen.

Once the space of Retzius has been dissected in the Mitek-MMK procedure,small anchors are secured in the pubic bone on either side of the pubicsymphysis. Each of the bone anchors has a suture attached thereto, andthese sutures are threaded through the periurethral tissue on eitherside of the urethra. The sutures are then tied off in the abdomen sothat the periurethral tissue is pulled upward, which in turn restoresthe angle of the urethra at the UVJ, thereby restoring the urethra toits proper location. While the Mitek-MMK procedure is highly effective,it is a lengthy and complicated procedure which can generally only beperformed by highly-skilled surgeons.

The present invention offers an alternative to the Mitek-MMK procedureswhich is not only highly effective, but also may be performedlaparoscopically.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the present invention, it is believed the samewill be better understood from the following description taken inconjunction with the accompanying drawings in which:

FIG. 1 is a cross-sectional view taken through the midline of a patientwho has lost support of the periurethral tissue at the UVJ, and isthereby suffering from stress urinary incontinence;

FIG. 2 is the same view as FIG. 1, however the structural defect hasbeen corrected using the method and apparatus of the present invention;

FIG. 3 is a top plan view of a bone anchor used in the method of thepresent invention;

FIG. 4 is a side plan view of the bone anchor of FIG. 3;

FIG. 5 is a top plan view of a drill tamper tool of the presentinvention wherein a portion of the tool has been broken-away;

FIG. 6 is a side plan view of the tamper tool of FIG. 5;

FIG. 7 is an end plan view of the tamper tool of FIG. 5, taken alongline 7--7 thereof;

FIG. 8 is a top plan view of a bone anchor insertion tool of the presentinvention, wherein a portion of the tool has been broken-away;

FIG. 9 is a side plan view of the insertion tool of FIG. 8;

FIG. 10 is a side plan view of the insertion tool of FIG. 8 with thebone anchor of FIG. 3 loaded thereon;

FIG. 11 is a side plan view of a suture retriever of the presentinvention;

FIG. 12 is an end plan view of the suture retriever of FIG. 11, takenalong the line 12--12 thereof;

FIG. 13 is a top plan view of a suture template of the presentinvention;

FIG. 14 is a side plan view of the template of FIG. 13;

FIG. 15 is a bottom plan view of the template of FIG. 13;

FIG. 16 is an end plan view of the template of FIG. 13, taken along line16--16 thereof;

FIG. 17 is a perspective view of the template of FIG. 13 in use during asurgical procedure with portions of the patient's anatomy cut-away forclarity;

FIG. 18 is a perspective view of an alternative embodiment of the suturetemplate according to the present invention;

FIG. 19 is a perspective view of the insertion tool of FIG. 8 in useduring a surgical procedure with portions of the patient's anatomycut-away for clarity;

FIG. 20 is a perspective view of the surgical procedure of the presentinvention wherein portions of the patient's anatomy cut-away forclarity, and wherein the suture retriever of FIG. 11 is being employed;

FIG. 21 is a perspective view of the surgical procedure of the presentinvention wherein portions of the patient's anatomy cut-away forclarity, and wherein the sutures have been retrieved from thepre-peritoneal region for tying; and

FIG. 22 is a perspective view of the space of Retzius, and illustratesthe proper placement of the anchors and sutures employed in the presentinvention.

SUMMARY OF THE PREFERRED EMBODIMENTS

In accordance with one aspect of the present invention, a sutureretrieval tool for use in a laparoscopic urethropexy procedure isprovided.

The suture retrieval tool comprises:

(a) a retrieving end, said retrieving end comprising a rigid, rod-likeshaft and a sharp tip capable of penetrating periurethral tissue, saidshaft having a longitudinal axis; and

(b) a handle, said handle having a longitudinal axis;

whereby said retrieving end may be inserted into a vagina, through thevaginal mucosa and periurethral tissue adjacent a urethra, and into thespace of Retzius, such that said retrieving end may be employed to snarea suture positioned in the space of Retzius for retrieving said sutureinto the vagina. The suture retrieval tool further preferably comprisesa midshaft positioned between said retrieving end said handle. Themidshaft and said shaft of said retrieving end are secured to oneanother in an angular relationship, and said handle and said midshaftare secured to one another in an angular relationship, such that theangle between said midshaft and said shaft of said retrieving end isapproximately equivalent to the angle between said handle and saidmidshaft, thereby positioning the longitudinal axis of said shaft of theretrieving end substantially parallel to the longitudinal axis of saidhandle. Preferably, both of these angles are between about 50 and about80 degrees, so that when said retrieving end is inserted into the spaceof Retzius of a patient in order to snare a suture therein, said handlewill be positioned outside of the patient's vagina in order tofacilitate manipulation of said retrieving end in the space of Retzius.

The diameter of the midshaft is also preferably greater than thediameter of said shaft of said retrieving end, such that the end of saidmidshaft adjacent said shaft of said retrieving end will act as a stoppreventing the midshaft from penetrating soft tissue when saidretrieving end is inserted through the soft tissue of a patient. Inorder to facilitate snaring of the suture, the retrieving end furthercomprises a return leg, said return leg extending from said sharp tipparallel to, and spaced from said rod-like shaft, such that said returnleg, the underside of said sharp tip, and said rod-like shaft define aU-shaped region capable of snaring a suture therein when said U-shapedregion is pulled over a suture. The surfaces of said return leg, theunderside of said sharp tip, and said rod-like shaft are should also besufficiently rounded and smooth so as to prevent nicking or fraying of asuture snared within said U-shaped region. The retrieving end shouldalso have a length sufficient to provide access to the space of Retziusin a patient when said retrieving end is fully inserted into the vaginaand through the vaginal mucosa and periurethral fascia adjacent theurethra, but not so long as to permit said sharp tip to penetrate beyondthe space of Retzius. The retrieving end is preferably stainless steel,and said midshaft and said handle are preferably plastic and may besingularly molded.

A surgical method for vaginally retrieving a suture extending from ananchor, said anchor secured within a bore in the pubic bone of apatient, said bore positioned adjacent the space of Retzius above theperiurethral fascia, is also provided. This method comprises the stepsof:

(a) providing a suture retrieving tool, said retrieving tool comprising:

a metal retrieving end, said retrieving end comprising a rigid, rod-likeshaft, a sharp tip capable of penetrating periurethral tissue, saidshaft having a longitudinal axis, and a return leg extending from saidsharp tip parallel to, and spaced from said rod-like shaft, such thatsaid return leg, the underside of said sharp tip, and said rod-likeshaft define a U-shaped region capable of snaring a suture therein whensaid U-shaped region is pulled over a suture.;

a handle, said handle having a longitudinal axis; and

a midshaft positioned between said retrieving end and said handle;

(b) inserting said retrieving end into the patient's vagina;

(c) forcing said sharp tip through the vaginal mucosa and periurethralfascia adjacent the urethra at a predetermined location;

(d) pushing said retrieving end upwardly into the space of Retzius bymeans of said handle so that said U-shaped region is positioned directlyabove said suture;

(e) pulling said retrieving end downwardly by means of said handle so asto snare said suture within said U-shaped region;

(f) continuing to pull said retrieving end downwardly by means of saidhandle until said retrieving end is completely pulled back into thevagina, such that said suture will also be pulled into the vagina.

The U-shaped region is preferably sized so that said suture freelyslides therewithin as said retrieving end is pulled back into thevagina, thereby ensuring that said suture is not damaged during theretrieval process. In addition, the handle remains substantially outsideof the vagina during the retrieval process, thereby facilitatingmanipulation of the retrieving end within the patient.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings in detail, wherein like numerals indicateidentical elements throughout the views, FIG. 1 is a cross-sectionalview taken along the midline of a patient suffering from stress urinaryincontinence. For reference, FIG. 1 depicts bladder 1, urethra 2,urethrovesicular junction (UVJ) 3, periurethral tissue 4, vagina 5,uterus 6, pubic symphysis 7, and space of Retzius 8. In this patient,urethra 2 and the associated periurethral tissue 4 have sagged intovagina 5. During periods of stress such as coughing or sneezing,pressure will be exerted on bladder 1. Due to the collapse of urethra 2,the surrounding musculature will be unable to provide sufficientcounteractive pressure on urethra 2 to prevent loss of urine duringthese periods of stress. As known from the methods of the prior art,particularly the MMK procedure, fixation of periurethral tissue 4 at UVJ3 on either side of urethra 2 will act to support the urethra andprevent the sagging of urethra 2 into vagina 5. This in turn will enablethe surrounding musculature to provide sufficient pressure on urethra 2to prevent loss of urine during moments of stress.

FIG. 2 depicts the resulting support of urethra 2 at UVJ 3 by means ofthe surgical procedure of the present invention. It should first benoted that pubic bone 12 is shown in FIG. 2, and is that portion of thepubic bone lying immediately to the right of the pubic symphysis. Aswill be more fully understood later, the anchors of the presentinvention are secured in the pubic bone on either side of the pubicsymphysis. A bore 13 has been produced in pubic bone 12, and anchor 9has been secured within bore 13. It should be noted that bore 13 andanchor 9 have been enlarged for purposes of clarity. A suture 10 issecured to anchor 9, and the two tails of suture 10 extend downwardlythrough the space of Retzius 8 into vagina 5. The tails of suture 10extend into the vagina immediately to the right of urethra 2 throughperiurethral tissue 4 at UVJ 3. In the vagina, the two tails of suture10 are tied to one another such that suture 10 provides an upward forceon periurethral tissue 4 on the right side of urethra 2 adjacent UVJ 3.An identical anchor and suture combination is secured to the pubic boneon the left side of the pubic symphysis, and the suture enters thevagina in a similar fashion as before in order to provide an upper forceon periurethral tissue 4 on the left side of urethra 2. In this fashion,the sutures on either side of the urethra act to restore the angle ofthe urethra at the UVJ.

As will be described in further detail below, the securing of theanchors to pubic bone 12 can be accomplished laparoscopically. Suture 10may then be pulled into vagina 5 through periurethral tissue 4immediately adjacent to urethra 2. The two tails of suture 10 may thenbe tied to one another within vagina 5 by hand. It has been found thatthe portion of suture 10 positioned within vagina 5 will beepithelialized within a few days after the procedure. In this fashion,suture 10 will not cause any discomfort or irritation to the patientsince suture 10 will quickly be covered by the epithelium of vagina 5.

Surgical Technique

A. Preparatory Procedures

Identification of patients suitable for the techniques of the presentinvention may be made by any of the known techniques for identifyingpatients amenable to SUI correction by MMK or similar procedures. Forexample, as discussed previously a cotton swab may be inserted into theurethra until the end of the swab reaches the UVJ. The patient is thenasked to bear down and the movement of the portion of the swab outsideof the urethra is monitored. The external urethral meatus will act as afulcrum for the cotton swab, and a loss of urethral support at the UVJcan be readily identified by the upward movement of the external end ofthe cotton swab. This indicates a downward descent of the urethra at theUVJ, which in turn provides an indication of the structural cause of thepatient's SUI. Other means known in the art, however may be employed toconfirm the diagnosis and/or to rule out other possible causes.

The preoperative preparation of the patient follows standard proceduresfor laparoscopic and gynecological surgeries, however no enema isneeded. The patient is placed in the dorsal lithotomy position, andstandard parenteral antibiotics are applied. Preferably, the patient isalso placed under general anesthesia in order to minimize discomfort.

A Foley catheter (16 French with 10 cc balloon) is then inserted intothe urethra. The balloon of the Foley catheter is inflated, and thecatheter is gently pulled outwardly to ensure proper placement of theballoon at the juncture of the bladder and the urethra. Proper placementof Foley catheter 14 is shown in FIG. 17 wherein a portion of vagina 5has been cut-away for purposes of clarity. Bladder 1 is thereafterdrained in the usual fashion using the Foley so that the bladder willbecome deflated. As will be understood below, maintaining the bladder ina deflated state greatly simplifies the procedure of the presentinvention. In addition, when the template of the present invention isemployed, it is preferable that Foley catheter 14 be positioned in themanner shown in FIG. 17 for reasons which will be described furtherherein.

It is also desirable to measure the length of the patient's urethra inorder to ensure proper placement of the supporting sutures, particularlywhen the template of the present invention is employed. If the suturesare placed too close to the bladder, there is a considerable risk thatthe suture retrieving tool will puncture the bladder. Likewise, if thesutures are placed too far from the UVJ, then proper support of theurethra will not be accomplished. The length of urethra 2 may be readilymeasured by means of any suitable apparatus which may be inserted intothe urethra, as long as the surgeon can be certain that one end of thedevice is positioned at the juncture of the bladder and the urethra(i.e., the UVJ). The simplest means of obtaining this measurement is toprovide graduations along at least a portion of the length of Foleycatheter 14, as shown in FIG. 17. In this fashion, when the balloon ofthe Foley is properly inflated within the bladder and the catheterpulled outwardly to ensure proper seating of the balloon at the junctureof the bladder and the urethra, the length of the urethra can bedetermined using the graduations which will be readily visibleimmediately adjacent the end of urethra 2. While the average urethra is3 cm in length, this can often vary between about 2.7 and about 3.3 cm.As will be more fully understood below, the suture template employed inthe method of the present invention can thus be manufactured indifferent sizes to accommodate the differing urethra lengths. A minimumof two sizes for the template may be provided, and more preferably atleast three different sizes. Alternatively, the graduations may beemployed to facilitate proper placement of a single-sized template.

After the placement of Foley catheter 14 and drainage of bladder 1, aninfraumbilical incision is made in the patient in order to provideaccess to the pre-peritoneal region (the area between the abdominal walland the peritoneum), and more particularly space of Retzius 8. Surgicaldissection of space of Retzius 8 is necessary in order to provide visualaccess to the pubic bone for placement of the bone anchors. Thus,dissection is performed below the fascia, thereby eliminating theadventitial or supportive connective tissue in space of Retzius 8.Although dissection of the connective tissue in space of Retzius 8 canbe accomplished in the typical fashion through a laparoscope, Applicanthas found that a balloon dissection procedure is simpler and moreeffective.

Balloon dissection can be accomplished using the SPACEMAKER surgicalballoon dissector manufactured by General Surgical Innovations ofPortola Valley, Calif., or an equivalent device. This device has a guiderod to which a small balloon is attached. The guide rod is inserted intothe infraumbilical incision until the tip of the rod reaches the pubicsymphysis in the space of Retzius (i.e., between the symphysis and thebladder). The balloon is then inflated in space of Retzius 8 by fillingthe balloon with approximately 300 cc of saline solution or othersuitable fluid, thereby further deflating bladder 1 and separating thesurrounding connective tissue in order to provide sufficient room inspace of Retzius 8 for the fixation procedure of the present invention.The balloon is then aspirated and removed from the pre-peritonealregion.

Although the SPACEMAKER device has an integral trocar which may normallybe left in the infraumbilical incision for placement of the laparoscope,the only size currently available is too small for the procedure of thepresent invention. Obviously a properly sized integral trocar couldremain in the patient after removal of the deflated balloon.Alternatively, and as presently preferred, the SPACEMAKER device isremoved in its entirety, and a larger 12 mm trocar is inserted into theinfraumbilical incision. A 12 mm WOLF operating/laser laparoscope(preferably with a WOLF 50/50 beamsplitter camera) is inserted into thetrocar. The pre-peritoneal region is then insufflated, preferably withCO₂ at a pressure between about 10 and about 30 mm Hg, thereby furtherexpanding the space of Retzius and providing excellent laparoscopicvision in this region.

Although the balloon dissection procedure is highly effective, furtherdissection of the space of Retzius is typically necessary in order toprovide the necessary access to the pubic bone and the periurethraltissue. Although this may be accomplished by means of a CO₂ laser or aelectrocautery device through the laparoscope already inserted, it ispresently preferred that an additional 5 mm trocar be inserted in themidline suprapubically. A irrigation/suction/bovie device (such as thatmanufactured by US Surgical) is then inserted into the space of Retziusthrough the smaller trocar. This device will not only assist in furtherdissection of the space of Retzius, but will also provide the necessaryirrigation and suction while the other instruments necessary forperforming the present procedure are employed through the infraumbilicaltrocar. The result of further dissection is that vision far superior tothe standard MMK or Burch procedures employing a full abdominal incisionwill be provided, since it is difficult in these procedures for thesurgeon to see the underside of the pubic bone where the anchors must beplaced without the surgeon placing his or her head on the stomach of thepatient. In this fashion, unobstructed laparoscopic access to the pubicbone and the periurethral tissue necessary for performing the procedureof the present invention is provided.

B. Creation of Bore in Pubic Bone

It should initially be noted that the procedure of the present inventionmay be employed with any of a variety of bone anchors, provided that theanchor can be readily secured to the pubic bone and a suture can beattached thereto. It is presently preferred, however, that the MITEKbone anchors known to those skilled in the art be employed for thispurpose. As discussed more fully herein, these anchors are secured inplace by pressing them into properly-sized bores created in the pubicbone.

The MITEK-MMK and related procedures require the use of either amechanical drill or hand-operated awl in order to provide the bore forinsertion of a bone anchor (such as those manufactured by Mitek SurgicalProducts, Inc.) into the pubic bone. While these devices may be readilyemployed with large abdominal incisions, they cannot be used through alaparoscope for a number of reasons. Most importantly, these tools mustbe sufficiently sharp to enable the surgeon to penetrate the hard outerlayers of the pubic bone (periosteum and cortical bone). Since the fieldof vision through a laparoscope may be limited at times, however, it isvery risky to employ such sharp implements as there is a tremendous riskof puncturing the bladder or other soft tissue in the operative area. Inaddition, as best shown in FIG. 12, pubic bone 12 falls away from thelaparoscope at an angle of approximately 45°. The angularity of pubicbone 12 therefore provides vision and operative difficulties which areovercome by the apparatus and methods of the present invention. Simplydrilling into pubic bone 12 using prior art apparatus through thelaparoscope is not advisable because the drill or awl tip will tend toslide downwardly during the drilling operation because of the manner inwhich pubic bone 12 angles downwardly away from the laparoscope. Whilethe drill tip may eventually penetrate the hard outer periosteum of thebone, the drill may enter at an improper location or angle due todownward slippage of the drill tip. Ideally one would like to produce abore in pubic bone 12 which is at an angle of approximately 45-degreesto the surface of the bone into which the bore is produced. This anglemay, however, be between about 20 and about 60-degrees, to therebyprovide sufficient support for the bone anchor to be placed in the borethus produced.

Applicant has developed a novel method and apparatus for creating therequired bores in the pubic bone through a laparoscope. The method andapparatus avoid the use of any sharp tips, while still enabling thesurgeon to properly place the bores in the pubic bone without a risk ofmisalignment during the bore creation process. In order to produce thebore without a need for a sharp instrument, a laser is first employed toproduce a cone-shaped crater in the pubic bone at the desired borelocation. The crater is produced in the periosteum and cortical bone,thereby providing access to the soft cancellous, or tribecular, bone. Inthis fashion, a drill tamper tool (to be described further herein) maythen be employed to create the properly-sized bore.

In order to create the starter "crater" in the pubic bone, a CO₂ laser(such as a SHARPLAN 20 watt) is inserted through the laparoscopicchannel, and is employed to create a cone-shaped crater slightly largerthan the diameter of the laser beam in the pubic bone on either side ofthe pubic symphysis. The diameter of the laser beam is preferably about2 mm, and therefore the cone-shaped crater created in the pubic bone isslightly larger than 2 mm in diameter. The crater should be sufficientlydeep to reach the cancellous bone. A crater is established on eitherside of the pubic symphysis directly above and approximately 1 cmlateral to the periurethral fascia at the UVJ. FIG. 21 depicts the spaceof Retzius after creation of bores 9 and 17 in pubic bone 12 on eitherside of pubic symphysis 7. The desired placement location can be readilydetermined through means of the optics of the laparoscope, as properdissection of space of Retzius 8 will provide sufficient vision forproper identification of the appropriate structures in the patient. Ifneeded, the surgeon may use one or more fingers to press upwardly on theperiurethral tissue on either side of the urethra within the vagina inorder to properly position the two starter craters in the pubic bone.

Once access to the cancellous bone has been provided by the cone-shapedcraters created on either side of the pubic symphysis using the laser,the bore for insertion of the anchor may be readily created using thedrill tamper tool of the present invention. Since the cancellous bone issignificantly softer than the periosteum or cortical bone, it is notnecessary that a sharp awl or drill bit be used to create the bore.Rather, a bluntly pointed drill tamper tool may be used, wherein the endof the tamper tool is not sufficiently sharp to puncture the bladder orother soft tissue under normal use. This provides a significantadvantage in that damage to the bladder or other soft tissue structuresand the patient may be readily avoided, and drill guides and the likewhich must be used with the MITEK Instruments and similar apparatus canbe avoided. As will be understood, the MITEK drill guides cannotpossibly be employed laparoscopically. The laser employed to create thecone-shaped craters can be readily aligned in the proper location,without risk of slippage or other inadvertent movement during theprocedure. The laser-created craters can then be readily employed toinsure that the bores for anchor placement are created in the exact,desired location.

The drill tamper tool of the present invention is shown in FIGS. 5-7 andcomprises an elongate rigid member 20 having a distal end whichcomprises a conical boring tip 21. End 22 of conical boring tip 21preferably has a cross section similar in size and shape to the cratercreated in the pubic bone by the laser. In this fashion, alignment ofconical boring tip 21 within the crater will be relatively easy. It isalso preferred that end 22 of conical boring tip 21 be blunt so that itwill not penetrate soft tissue such as the bladder during normal use(i.e., not sufficiently sharp to penetrate soft tissue or organs duringnormal use). Certainly, however, conical boring tip 21 should besufficiently thin and blade-like to permit boring tip 21 to create thebore in the soft cancellous bone by use of hand force through thelaparoscope. In this regard, conical boring tip 21 is preferably shapedsimilar to a flat bladed screwdriver. Thus, boring tip 21 has taperedside surfaces 23 and 24 which terminate in portion 25 which is of acircular cross-section. The diameter of circular-crossection portion 25is identical to the diameter of the bore which will be created in thepubic bone. By rotating the drill tamper tool while simultaneouslypressing boring tip 21 into the crater in the pubic bone, the desiredbore will be readily created therein. The diameter of portion 25 is alsoapproximately the same as the body of the anchor to be inserted into thebore.

In order to ensure sufficient support for the bone anchors of thepresent invention, it is also important that the anchor be seated deepwithin the pubic bone. In order to ensure proper depth of the bore,therefore, collar 26 is provided on the drill tamper tool. Collar 26 isof a larger diameter than conical boring tip 21, and therefore will actas a stop preventing further penetration of the drill tamper tool intothe bone. Although collar 26 is shown as tapering in diameter betweenconical boring tip 21 and intermediate portion 27, it is also possiblethat collar 26 simply comprise a non-tapered end of intermediate portion27. Intermediate portion 27 has a diameter significantly greater thanthat of conical boring tip 21, and is positioned on the opposite end ofcollar 26. Intermediate portion 27 not only allows the provision ofcollar 26, but also adds rigidity to the tamper tool. Intermediateportion 27, however, should be significantly smaller in diameter thanthe operative channel of the laparoscope so that sufficient vision ofthe operative region is provided. Preferably, the length of conicalboring tip 21 is between about 1, and 3 cm, and most preferably about1.4 cm. Intermediate portion 27 is preferably between about 2, and 6 cm,and most preferably about 5 cm.

In order to provide stability during the boring procedure, cylindricalguide portion 28 is also included on the drill tamper tool. Guideportion 28 has first end 29 and second end 30. First end 29 is attachedto intermediate portion 27 at the opposite end of collar 26. Cylindricalguide portion 28 preferably has a diameter slightly less than theoperative channel of the laparoscope. In this fashion, guide portion 28provides the necessary stability within the laparoscope to ensure properplacement of the bores. Second end 30 of guide portion 28 is preferablyattached to handle 31. While handle 31 is shown as having a flat endportion 32 and curved hand grip surfaces 33, handle 31 can be of avariety of forms and still be sufficient for purposes of the presentinvention. Handle 31 facilitates the proper manipulation of conicalboring tip 21 through the laparoscope, and provides a sufficiently firmsurface 32 upon which force may be applied to complete the boringoperation. Guide portion 28 preferably has a length between about 50 andabout 55 cm, and most preferably about 52 cm. The overall length of thedrill tamper tool of the present invention therefor permits sufficientaccess to the pubic bone, while also providing anergonomically-effective boring operation through the laparoscope andensuring that the tool does not interfere with the anesthesiologist.

C. Insertion of Bone Anchors in Pubic Bone

The preferred anchor for use in the present invention is shown in FIGS.3 and 4, and is identical to that disclosed in U.S. Pat. No. 5,207,679,which is herein incorporated by reference. Anchor 9, which is preferablymade of titanium alloy or other suitable material, has a cylindricalbody 40 and a conical end 44 attached thereto. At least two flexiblebarbs 41 curve outwardly away from body 40. A groove 42 is provided oneither side of body 40 at the end opposite to conical end 44. Inaddition, cylindrical end 45 extends away from body 40 adjacent groove42. The longitudinal axis of cylindrical end 45 is aligned with thelongitudinal axis of body 40. The diameter of cylindrical end 45 ispreferably equivalent to the diameter of body 40 within grooves 42positioned on opposite sides of body 40. As will be understood below,this structure facilitates the attachment of anchor 9 to an insertiontool.

As best shown in FIG. 4, body 40 and cylindrical end 45 have an aperture43 provided therethrough. Aperture 43 is sized so as to accommodate asuture appropriate for the fixation procedure of the present invention.It is preferred that a size 0 GORE-TEX suture be employed, and thusanchor 9 and its accompanying aperture 43 should be sized accordingly.The use of a GORE-TEX suture is preferred for reasons of strength andnon-elasticity. Certainly other types of sutures could be employed ifnecessary. A portion of suture 10 is shown in FIG. 3 having beeninserted through aperture 43.

The insertion of anchor 9 is relatively straightforward, and merelyrequires that the anchor be pressed completely into the bore which haspreviously been created in the pubic bone. Preferably, anchor 9 isinserted into the bore in the pubic bone until conical end 44 reachesthe distal end of the bore. The bore should be at least as long as thelength of anchor 9, however, it is preferably considerably longer toensure sufficient support for the anchor. As anchor 9 is pressed intothe bore, flexible barbs 41 will be compressed against body 40 as theyare inserted past the hard periosteum and cortical bone surrounding thebore. Once within the bore, however, flexible barbs 41 will tend tospring back into the soft cancellous bone, thereby securing the anchorin place. A slight tug on the tails of the suture 10 will also causebarbs 41 to further deploy.

In order to insert anchor 9 into the bore previously created in thepubic bone, the anchor insertion tool shown in FIGS. 8-10 may beemployed. Thus, after the drill tamper tool has been employed to createthe necessary bores, the anchor insertion tool of the present inventionhaving an anchor and threaded suture loaded thereupon, is inserted intothe laparoscope for proper seating of anchor 9.

The anchor insertion tool of the present invention comprises a rigidelongate member 50 having a handle 51 at one end, and ananchor-receiving tip 52 at the opposite end of elongate member 50. Aswas the case with the drill tamper tool, handle 51 can be of anyvariety, and that shown is only the presently-preferred embodiment ofthis handle. Anchor-receiving tip 52 is similar in construction to thatshown in FIGS. 4-6 of U.S. Pat. No. 5,207,679. Anchor-receiving tip 52is constructed so as to matingly receive anchor 9 in order to facilitateinsertion of anchor 9 into the bore. As will be apparent, thelongitudinal axis of anchor-receiving tip 52 should be aligned with thelongitudinal axis of elongate member 50. Anchor-receiving tip 52 iscylindrical in nature, having a diameter approximately equivalent tobody 40 of anchor 9. In this manner, at least a portion ofanchor-receiving tip 52 may pass through the bore in the pubic boneduring the anchor insertion process to properly seat the anchorcompletely within the bore.

Anchor-receiving tip 52 has a pair of guide tabs 53 extending from theend of anchor-receiving tip 52 on either side thereof. Guide tabs 53 aresized and shaped so as to be matingly received within grooves 42positioned on either side of anchor 9. Anchor-receiving tip 52 also hasa cylindrical slot 54 aligned with the longitudinal axis of tip 52.Cylindrical slot 54 should correspond in size and shape to cylindricalend 45 of anchor 9 in order to matingly receive the same. It is alsopreferable that the distance between guide tabs 53 be slightly smallerthan the distance between the corresponding grooves 42 on anchor 9. Inthis fashion, guide tabs 53 as well as cylindrical slot 54 will applycompressive force against anchor 9 thereby more securely holding anchor9 in place when loaded within anchor-receiving tip 52.

Since suture 10 will extend outwardly on either side of anchor 9, it ispreferable to provide a means for ensuring that suture 10 is not abradedby the bone surrounding the bore during the insertion process. Thus, apair of tapered grooves 55 are provided on either side of the anchorinsertion tool, and extend from the end of anchor-receiving tip 52 alongat least a portion of the length of elongate member 50. As best shown inFIG. 10 wherein anchor 9 has been loaded upon the insertion tool,grooves 55 ensure that the sutures will be protected by anchor-receivingtip 52 and a portion of elongate member 50 during the insertion process.Since any nicks in the suture may compromise the strength and permanencyof the fixation, it is important to ensure that the suture is notdamaged in any fashion.

Anchor-receiving tip 52 should also be of the proper length to ensuredeep placement of anchor 9 completely within the bore. Thus, the lengthof the combination of anchor-receiving tip 52 and bone anchor 9 whenloaded in the manner shown in FIG. 10 should be equivalent to the sizeof the bore created in the pubic bone. Since the diameter of elongatemember 50 is significantly greater than that of anchor-receiving tip 52,distal end 56 of elongate member 50 will firmly abut the pubic bone oncethe anchor has been completely inserted into the bore. In this manner,the surgeon can be certain that the anchor has been seated to itscomplete and proper depth.

As was the case with the drill tamper tool of the present invention,elongate member 50 further comprises an intermediate section 57 and aguide portion 58. Intermediate portion 57 should have a diametersufficiently less than that of the laparoscope in order to provideadequate vision for the surgeon, and intermediate portion 57 also hasdistal end 56 described above. Preferably, intermediate portion 57 has alength between about 2 and about 6 cm, most preferably about 5 cm. Itshould be kept in mind that, as shown in FIG. 10, suture 10 will extendalong the length of intermediate portion 57 on either side thereof. Thisconsideration must be kept in mind when sizing the diameter ofintermediate portion 57 to ensure not only that it can be easilyinserted through the laparoscope, but also to ensure adequate vision.

Guide portion 58 will necessarily be slightly smaller than the diameterof the guide portion for the drill tamper tool previously described,since, as shown in FIG. 10, suture 10 will extend along either side ofguide portion 58. With this in mind, the total of the diameter of guideportion 58 and twice the diameter of suture 10 should be only slightlyless than the inside diameter of the operative channel of thelaparoscope. In this fashion, guide portion 28 provides a rigid supportfor the surgeon during the anchor insertion process. Preferably, guideportion 58 has a length between about 50 and 55 cm., most preferablyabout 52 cm. This provides an overall inserter length comparable to thatof the drill tamper tool, thereby providing the same advantages withregard to the tamper tool length.

In order to effectively employ the procedure of the present inventionlaparoscopically, it is necessary that the two tails of suture 10 becontrolled as much as possible. If the sutures are permitted to hangaway from anchor 9 or the anchor insertion tool, the tails willgenerally become balled within the space of retzius, thereby making thesuture tying procedure difficult, if not impossible. Although thesutures may be held against the anchor insertion tool by hand, Applicanthas developed a more effective manner of accomplishing this. Thus, firstand second shouldered depressions 59 and 60 are preferably providedabout the circumference of guide portion 58. A small rubber band 61 (asshown in FIG. 10), or other suitable elastic band, may be held withineach of the two shouldered depressions, with the two tails of suture 10held beneath rubber band 61 on either side of guide portion 58 as shown.First shouldered depression 59 is preferably positioned approximately 10cm from the ends of guide tabs 53. Second shouldered depression 60 ispreferably positioned about 40 cm from guide tabs 53. Both shouldereddepressions act, in conjunction with an elastic band contained therein,to hold suture 10 in place on the sides of the anchor insertion tool.

In addition to holding the suture in place on the anchor insertion tool,the shouldered depression/elastic band combination further improves thelaparoscopic procedure of the invention by not only assisting in seatingthe anchor, but also in the suture retrieval process. As shown in FIG.20, the anchor insertion tool of the present invention, with apre-loaded anchor and suture assembly attached thereto, is insertedthrough the laparoscope for placement of the anchor as previouslydescribed. Once the anchor has been seated within the bore, the anchorinsertion tool is then pulled outwardly utilizing handle 51 containedthereon. The combination of shouldered depressions 59 and 60 andrubberband 61 act to provide tension in suture 10 which in turn pullsoutwardly on anchor 9 which is now contained in the bore. This outwardforce on anchor 9 will cause flexible barbs 41 to extend outwardly intothe cancellous bone surrounding the bore, thereby further securinganchor 9 in position. In other words, this outward force on suture 10 bythe drag created by the shoulder depression/elastic band combinationwill act to deploy the previously compressed barbs 41 on anchor 9,thereby rigidly securing anchor 9 within the bore.

In order to facilitate the surgical procedure of the present invention,the drill tamper tool and the anchor-insertion tool described above maybe provided in the form of a reusable surgical kit.

D. Fixation of Periurethral Tissue at the UVJ via Suturing

Once the anchor and suture assembly have been secured within the borecreated in the pubic bone, it is next necessary to utilize the two tailsof the suture to elevate the periurethral tissue on the correspondingside of the urethra at the UVJ. Applicant has found that the mosteffective means for accomplishing this is to pull each tail of thesuture through the periurethral tissue into the vagina. In this fashion,the two tails may then be easily tied to one another within the vaginato provide the necessary support, and eliminating any need forlaparoscopic suture tying. Obviously, however, a means for retrievingthe suture tails must be provided.

The method of suture retrieval doing is best shown in FIG. 20, which isa perspective view of the procedure with portions of the patient'sanatomy cut-away for purposes of clarity. As shown in FIG. 20, as theanchor insertion tool of the present invention is partially withdrawnfrom the patient through the laparoscope, first shouldered depression 59in combination with rubberband 61 will cause both suture tails to betensioned between the anchor and the anchor insertion tool as shown.Were this not the case, the suture tails would merely fall into thespace of Retzius similar to a ball of yarn, and thereby be difficult (ifnot impossible) to retrieve. While the suture tails could be tensionedbetween the anchor and the anchor insertion tool by pulling outwardly onthe sutures, this would unnecessarily require an additional pair ofhands. Thus, the shouldered depression/rubber band combination is alsoeffective in this regard.

Once the anchor insertion tool has been partially removed in order totension the suture tails in the manner shown in FIG. 20, a sutureretrieving tool may be inserted into the vagina and then pressedupwardly on one side of the urethra into the space of Retzius in orderto retrieve one of the suture tails in the manner shown. Thus, thesuture retrieving tool must have a sharp point capable of passingcompletely through the full thickness of the periurethral fascia andvaginal mucosa adjacent the urethra. The suture retrieval tool must alsohave a means for grasping the suture tail and pulling the tail backthrough the full thickness of the periurethral and vaginal mucosa bymeans of the same entry hole created by the sharp point. Each tail ispulled into the vagina in this fashion at the proper location.Preferably, one tail is pulled into the vagina approximately 1 cm fromthe urethra at the UVJ, and the other tail is pulled into the vaginaapproximately 2 cm lateral from the urethra. In other words, each tailpenetrates the periurethral tissue along an imaginary line extendingsubstantially perpendicularly away from the urethra. Each tail may thenbe pulled out of the vagina for purposes of tying.

The suture tails are tied to one another using a series of standardsurgeon's knots, and each knot is slid by hand to the point in thevagina at which the suture tails were previously retrieved. The tailsare tied to one another in a sufficiently tight fashion so that suture10 creates an upward force on the periurethral tissue adjacent theurethra in order to elevate the urethra at the UVJ and restore theurethra to its proper angle. The position of the urethra can be readilyobserved by the surgeon as this procedure is performed, thereby ensuringthat the urethra is restored to the desired angle. The entire procedure(anchor insertion, suture retrieval, etc.) is then repeated for theanchor placed on the opposite side of the pubic symphysis, and thesuture tails of that anchor are pulled into the vagina through theperiurethral tissue on the opposite side of the urethra as the firstsuture tails. Tying is then performed in the same fashion, therebyelevating the other side of the urethra to thereby completely restorethe urethral angle at the UVJ.

The result of this process is best shown in FIG. 2, wherein it is shownthat suture 10, and the corresponding suture on the opposite side of theurethra have restored the urethra to its proper angle. It should benoted that at no time do the sutures pull upward directly beneath theurethra, since doing so would create the risk that the suture wouldcause urethral blockage. After tying, the remaining tails of suture 10are cut at the knot. The portion of suture 10 remaining in the vaginawill epithelize within three to four days, and the patient will nolonger sense that the sutures are in place. The result is a permanentfixation of the periurethral tissue on both sides of the urethra,thereby restoring the urethra to its correct angle and eliminating theSUI. After completion of the tying process, the surgical area within thepatient is flushed with a dilute lidocaine solution, the laparoscope andtrocars removed, a stronger lidocaine solution is applied to theincision sites, and the incisions are closed in the usual fashion. TheFoley catheter may then be removed, and the patient permitted to recoverin the usual fashion. Normal everyday activities may be resumed within2-3 days.

E. Suture Retriever

In order to pull the tails of suture 10 through the entire thickness ofthe periurethral fascia and vagina mucosa, various tools can beemployed. For example, a U.S. Surgical Auto-Stitch tool may beeffectively employed for this purpose. It is critical, however, that thetool employed being capable of readily be inserted through theperiurethral tissue from the vagina into the space of Retzius, whilealso being capable of grasping the suture tails. It is also criticalthat the surfaces contacting suture 10 be perfectly smooth in order toeliminate the risk of nicks or cuts in suture 10 which would obviouslycompromise the effectiveness of the procedure. Applicant has developed anovel suture retriever for accomplishing this purpose which provides aconvenient and simple means of retrieving the suture tails.

The suture retrieval tool of the present invention is depicted in FIG.11, and comprises metal retrieving end 65, midshaft 66, and handle 67.Midshaft 66 and handle 67 may be singularly molded from polycarbonate ora similar FDA-approved material in the typical fashion. As shown in FIG.12, handle 67 is also preferably knurled in order to facilitate graspingand manipulation of the retriever. Metal retrieving end 65 is preferablymade of stainless steel and can be securely molded into distal end 68 ofmidshaft 66.

Metal retrieving end 65 comprises a rigid, rod-like shaft 69, and asharp tip 70 capable of penetrating the periurethral tissue. Thediameter of distal end 68 is preferably significantly greater than thatof shaft 69, and will act as a stop in order to limit the penetration ofthe suture retrieval tool into the space of Retzius. Thus, the length ofshaft 69 and tip 70 may be selected so as to ensure that when the sutureretrieval tool is inserted into the space of Retzius through the vaginathat sharp tip 70 will generally be incapable of striking anysurrounding soft tissue.

Retrieving end 65 further comprises a return leg 71 which extends awayfrom sharp tip 70 in the same direction of shaft 69. Shaft 69, returnleg 71 and the underside of sharp tip 70 thus create an invertedU-shaped region capable of ensnaring suture 10 for retrieval purposes.The distance between return leg 71 and shaft 69 in the region of theinverted U-shape is preferably approximately the same diameter as suture10. In this fashion, and as shown in FIG. 20, after sharp tip 70 haspenetrated the periurethral tissue adjacent the vagina in order to enterthe space of Retzius, the inverted U-shape may be pulled downwardly overa suture tail, thereby snaring the suture. Metal retrieving end 65 maythen be pulled back through the periurethral tissue, and the tail ofsuture 10 will remain snared between return leg 71 and shaft 69 directlybeneath sharp tip 70. Although the suture tail will slide within theU-shaped region, it will nevertheless be pulled into the vagina.

One critical feature of the suture retriever of FIG. 12 is that theinner surfaces of metal retrieving end 65 which contact suture 10 mustbe rounded and smooth in order to permit suture 10 to freely slidewithin the inverted U-shaped portion as the retriever is withdrawn. Thisprevents nicking or fraying of the suture while still permitting thesuture tail to be withdrawn. Thus, the only sharp portion of metalretrieving end 65 is sharp tip 70.

While it is possible that handle 67, midshaft 66, and metal retrievingend 65 may all be positioned along the same longitudinal axis therebyforming a rigid, elongate structure, Applicant has found that theprocess of the present invention can be simplified if the elements ofthe retriever have the angular relationship indicated in FIG. 11. Thisis particularly true when the template of the present invention (to bedescribed further herein) is employed. Thus, metal retrieving end 65preferably is positioned at an angle of between about 50 degrees andabout 80 degrees, most preferably about 60 degrees, to midshaft 66 (thisangle is indicated as A in FIG. 11). Likewise, handle 67 is preferablypositioned at an angle of between about 50 degrees and about 80 degrees,most preferably about 60 degrees, to handle 67 (this angle is indicatedas B in FIG. 11 ). Thus, the longitudinal axis of shaft 69 of metalretrieving end 65 will be parallel to the longitudinal axis of handle67. In this fashion, when the retriever of the present invention isemployed midshaft 66 will generally be positioned parallel to thelongitudinal axis of the vagina. Metal retrieving end 65 will thenextend upwardly through the periurethral tissue into the space ofRetzius as desired. As best shown in FIG. 20, handle 67 will therebyextend downwardly outside of the vagina, and thus sharp tip 70 may bereadily forced through the periurethral tissue as desired merely bypushing upwardly on handle 67.

As shown in FIG. 11, the transitions between handle 67 and midshaft 66as well as between midshaft 66, and retrieving end 65 should be gentlycurved in order to ease placement. It should be noted that angles A andB can vary significantly, however it is preferred that they be as closeto one another as possible so that the parallel relationship of handle67 and retrieving end 65 is maintained. In addition, the presentconfiguration ensures that the retrieving end 65 will enter the space ofRetzius at an angle of approximately 90 degrees to the tensioned suturetails (i.e., the suture tails tensioned between the anchor and theanchor insertion tool). This perpendicular relationship allows foreffective snaring of the suture, as well as improved vision of theretrieval through the laparoscope.

Preferably, midshaft 66 is between about 2 and about 6 cm. in length,most preferably about 4 cm. The cross-sectional area of midshaft 66should merely be a size chosen to provide the necessary rigidity whilealso not blocking vision within the vagina during the procedure.Likewise, handle 67 is preferably about 4 cm long, however the length isnot as critical since handle 67 remains completely outside of the body.The diameter of handle 67 should be chosen so as to provide acomfortable and secure means of grasping the suture retrieval tool.Preferably, handle 67 is about 3 cm in diameter.

F. Surgical Template

While the placement of the sutures at the UVJ may be accomplished bymerely feeling for the correct location within the vagina by hand,particularly in relation to the ball of the Foley catheter, Applicanthas developed a novel template which greatly simplifies proper placementof the sutures. This device not only prevents bladder injury, urethralinjury, or vascular accidents, the template also ensures a properdistance between the two suture tails to ensure that there is adequateperiurethral tissue between the tails to provide the necessary support.Obviously if the suture tails are placed too close to one another, thereis a risk that the suture will tear through the periurethral tissue andeliminate the fixation. Thus, a template is provided wherein thetemplate has at least two apertures which may be properly positioned oneither side of the urethra. The suture retriever may then be insertedthrough these apertures and thereafter through the periurethral tissuein order to snare the suture tails in the manner described previously.

The presently preferred template is depicted in FIGS. 13-17. Thetemplate comprises a trough 80 of arcuate cross-section, wherein trough80 is sized so as to cradle the patient's urethra when properlypositioned. First and second wing members 81 and 82 extend away fromopposite sides of trough 80, preferably perpendicularly to thelongitudinally axis of trough 80 in the manner shown. Most preferablywing members 81 and 82 extend perpendicularly away from opposite sidesof trough 80 at the upper most edges 83 and 84 of trough 80. First andsecond suture guide apertures 85 and 86 are positioned in each of thewing members 81 and 82 as shown. The guide apertures are positioned sothat when the urethra of the patient is properly positioned withintrough 80, guide apertures 85 and 86 on each wing will indicate theproper location for the sutures. First suture guide aperture 85 ispositioned so that the first tail of suture 10 will penetrate theperiurethral tissue approximately 1 cm from the urethra adjacent theUVJ. Second guide aperture 86 is preferably positioned about 1 cmfurther away from the urethra along a line perpendicular to thelongitudinal axis of trough 80. In other words, the distance betweenfirst suture guide aperture 85 and second suture guide aperture 86 ispreferably about 1 cm. In this manner, the surgeon can be confident thatsufficient periurethral tissue will be present between the two suturetails.

It is certainly possible that the template of the present invention maymerely be held in place by hand, and in fact the downwardly slopingnature of the underside wing members 81 and 82 are suitable forplacement of the surgeon's fingers thereunder. Additional alignmentmeans are preferably provided, however at a minimum, end wall 87 isprovided at the end of trough 80 furthest away from the suture guideapertures. Thus, as long as the template is properly sized for thelength of the patient's urethra, the surgeon may hold the template inplace with end wall 87 abutting the outermost end 89 of urethra 4 inorder to ensure proper alignment. For example, if the length of thepatient's urethra is determined to be three cm, the distance between endwall 87 and first and second guide apertures 85 and 86 should be betweenabout 2.5 and about 3.2 cm, most preferably about 2.8 cm. The guideapertures should also be between about 0.25 and about 0.5 cm from distalend 91 of the wing members (FIG. 13). As long as the template ispositioned with end wall 87 abutting the outermost portion of theurethra, the surgeon will be assured that the sutures will be properlyplaced without risk of puncturing the bladder, or urethra.

While the surgeon may employ two fingers beneath wing members 81 and 82to hold the template in the proper position, Applicant has found thatthe provision of arcuate alignment member 88 secured to end wall 87 maybe effectively employed for securing the template in place without theneed for the surgeon to hold the template in any manner. Alignmentmember 88 is preferably positioned parallel to trough 80, with thecenter line of alignment member 88 aligned with the center line oftrough 80. Alignment member 88 may either extend away from trough 80 asshown in FIG. 13, or alternatively may extend away from end wall 87directly along the interior of trough 80 as shown in FIG. 18.

When the embodiment of FIGS. 13-16 is employed, alignment member 88 ispreferably sized so that when the template is manufactured from aresilient material, alignment member 88 may be rigidly snapped aboutFoley catheter 14 as shown in FIG. 20. Thus, the shaft of Foley catheterwill be securely held within alignment member 88, and the surgeon needonly pull outwardly on the Foley catheter while sliding the templateinto the vagina towards the urethra until end wall 87 abuts end 89 ofurethra 2. The ball of the Foley catheter will thus be positioned at theUVJ, and the template will likewise be positioned at the appropriatelocation assuming that a template of the proper size has been selectedbased upon the length of the urethra.

As an alternative to providing various sizes for the template of thepresent invention, a single, larger-sized template may be employedprovided that alignment member 88 is snapped about the shaft of Foleycatheter 14 in the proper location. Thus, instead of abutting end wall87 against end 89 of urethra 2, end wall 87 is instead aligned with theappropriate graduation along the shaft of Foley catheter 14 based uponthe previously-measured length of the urethra. Likewise, end 90 ofalignment member 88 could alternatively be aligned with the appropriategraduation along the shaft of Foley catheter 14 in order to provide theproper placement of the template based upon the length of the patient'surethra.

FIG. 18 depicts yet another alternative embodiment for the template ofthe present invention in which alignment member 88 extends along theinterior of trough 80. In employing this embodiment, alignment member 88is inserted into the urethra along with Foley catheter 13 until end wall87 of the template abuts end 89 of urethra 2. As will be understood,therefor, an appropriately-sized template will ensure proper placementof the sutures.

Finally, the template of the present invention can be manufactured ofany suitable material such as polycarbonate or other FDA-approvedplastic. The template may be readily molded using known technology, andis preferably manufactured as a disposable, single-use item. The drilltamper tool and anchor insertion tools, on the other hand, should bemade from medical-grade stainless steel. The handles, however, may bepolycarbonate or other FDA-approved plastic.

What I claim is:
 1. A suture retrieval tool for use in a urethropexyprocedure, said retrieval tool comprising:(a) a retrieving end, saidretrieving end comprising a rigid, rod-like shaft and a sharp tipcapable of penetrating periurethral tissue, said shaft having alongitudinal axis; (b) a handle, said handle having a longitudinal axis;and (c) a midshaft positioned between said retrieving end and saidhandle wherein said midshaft and said shaft of said retrieving end aresecured to one another in an angular relationship, and wherein saidhandle and said midshaft are secured to one another in an angularrelationship, and further wherein said angular relationships and thelength of said retrieving end are such that said retrieving end may beinserted into a vagina, through the vaginal mucosa and periurethraltissue adjacent a urethra, and into the space of Retzius, with at leasta portion of said handle remaining substantially outside of the vagina,such that said retrieving end may be employed to snare a suturepositioned in the space of Retzius for retrieving said suture into thevagina.
 2. The suture retrieval tool of claim 1, wherein the anglebetween said midshaft and said shaft of said retrieving end isapproximately equivalent to the angle between said handle and saidmidshaft, thereby positioning the longitudinal axis of said shaft of theretrieving end substantially parallel to the longitudinal axis of saidhandle.
 3. The suture retrieval tool of claim 2, wherein the diameter ofsaid midshaft is greater than the diameter of said shaft of saidretrieving end, such that the end of said midshaft adjacent said shaftof said retrieving end will act as a stop preventing the midshaft frompenetrating soft tissue when said retrieving end is inserted through thesoft tissue of a patient.
 4. A suture retrieval tool for use in alaparoscopic urethropexy procedure, said retrieval tool comprising:(a) aretrieving end, said retrieving end comprising a rigid, rod-like shaftand a sharp tip capable of penetrating periurethral tissue, said shafthaving a longitudinal axis; and (b) a handle, said handle having alongitudinal axis;wherein said retrieving end further comprises a returnleg, said return leg extending from said sharp tip substantiallyparallel to, and spaced from said rod-like shaft, such that said returnleg, the underside of said sharp tip, and said rod-like shaft define aU-shaped region capable of snaring a suture therein when said U-shapedregion is pulled over a suture, and further wherein the length of saidretrieving end is such that said retrieving end may be inserted into avagina, through the vaginal mucosa and periurethral tissue adjacent aurethra, and into the space of Retzius, so that said retrieving end maybe employed to snare a suture positioned in the space of Retzius forretrieving said suture into the vagina.
 5. The suture retrieval tool ofclaim 4, wherein the surfaces of said return leg, the underside of saidsharp tip, and said rod-like shaft are sufficiently rounded and smoothso as to prevent nicking or fraying of a suture snared within saidU-shaped region.
 6. The suture retrieval tool of claim 4, wherein saidretrieving end has a length sufficient to provide access to the space ofRetzius in a patient when said retrieving end is fully inserted into thevagina and through the vaginal mucosa and periurethral fascia adjacentthe urethra, but not so long as to permit said sharp tip to penetratebeyond the space of Retzius.
 7. A suture retrieval tool for use in aurethropexy procedure, said retrieval tool comprising:(a) a metalretrieving end, said retrieving end comprising a rigid, rod-like shaft,a sharp tip capable of penetrating periurethral tissue, said shafthaving a longitudinal axis, and a return leg extending from said sharptip parallel to, and spaced from said rod-like shaft, such that saidreturn leg, the underside of said sharp tip, and said rod-like shaftdefine a U-shaped region capable of snaring a suture therein when saidU-shaped region is pulled over a suture; (b) a handle, said handlehaving a longitudinal axis; and (c) a midshaft positioned between saidretrieving end and said handle;whereby said retrieving end may beinserted into a vagina, through the vaginal mucosa and periurethraltissue adjacent a urethra, and into the space of Retzius, such that saidU-shaped region of said retrieving end may be employed to snare a suturepositioned in the space of Retzius for retrieving said suture into thevagina.
 8. The suture retrieval tool of claim 7, wherein said midshaftand said rod-like shaft are secured to one another in an angularrelationship, and wherein said handle and said midshaft are secured toone another in an angular relationship, such that the angle between saidmidshaft and said rod-like shaft is approximately equivalent to theangle between said handle and said midshaft, thereby positioning thelongitudinal axis of said shaft of the retrieving end substantiallyparallel to the longitudinal axis of said handle.
 9. The sutureretrieval tool of claim 7, wherein said retrieving end has a lengthsufficient to provide access to the space of Retzius in a patient whensaid retrieving end is fully inserted into the vagina and through thevaginal mucosa and periurethral fascia adjacent the urethra, but not solong as to permit said sharp tip to penetrate beyond the space ofRetzius.
 10. A surgical method for vaginally retrieving a sutureextending from an anchor, said anchor secured within a bore in the pubicbone of a patient, said bore positioned adjacent the space of Retziusabove the periurethral fascia, comprising the steps of:(a) providing asuture retrieving tool, said retrieving tool comprising:a metalretrieving end, said retrieving end comprising a rigid, rod-like shaft,a sharp tip capable of penetrating periurethral tissue, said shafthaving a longitudinal axis, and a return leg extending from said sharptip parallel to, and spaced from said rod-like shaft, such that saidreturn leg, the underside of said sharp tip, and said rod-like shaftdefine a U-shaped region capable of snaring a suture therein when saidU-shaped region is pulled over a suture; a handle, said handle having alongitudinal axis; and a midshaft positioned between said retrieving endand said handle; (b) inserting said retrieving end into the patient'svagina; (c) forcing said sharp tip through the vaginal mucosa andperiurethral fascia adjacent the urethra at a predetermined location;(d) pushing said retrieving end upwardly into the space of Retzius bymeans of said handle so that said U-shaped region is positioned directlyabove said suture; (e) pulling said retrieving end downwardly by meansof said handle so as to snare said suture within said U-shaped region;(f) continuing to pull said retrieving end downwardly by means of saidhandle until said retrieving end is completely pulled back into thevagina, such that said suture will also be pulled into the vagina. 11.The surgical method of claim 10, wherein said U-shaped region is sizedso that said suture freely slides therewithin as said retrieving end ispulled back into the vagina, thereby ensuring that said suture is notdamaged during the retrieval process.
 12. The surgical method of claim10, wherein said handle remains substantially outside of the vaginaduring the retrieval process, thereby facilitating the manipulation ofthe retrieving end during the retrieval process.
 13. A surgical methodfor vaginally retrieving a suture extending from an anchor during aurethropexy procedure, said anchor secured to the pubic bone of apatient, comprising the steps of:(a) providing a suture retrieval tool,said retrieval tool comprising:a retrieving end, said retrieving endcomprising a shaft and a sharp tip capable of penetrating periurethraltissue; and a handle; (b) inserting said retrieving end into thepatient's vagina; (c) forcing said sharp tip through the vaginal mucosaand periurethral fascia adjacent the urethra; (d) pushing saidretrieving end upwardly by means of said handle towards said suture; (e)snaring said suture with said retrieving end; (f) pulling saidretrieving end downwardly by means of said handle until said retrievingend is completely pulled back into the vagina, such that said suture isalso pulled into the vagina.
 14. The surgical method of claim 15,wherein at least a portion of said handle remains substantially outsideof the vagina during the retrieval process, thereby facilitatingmanipulation of the retrieving end during the retrieval process.
 15. Thesurgical method of claim 14, wherein said suture retrieval tool furtherhas a midshaft positioned between said retrieving end and said handle,wherein the diameter of said midshaft is greater than the diameter ofsaid retrieving end, such that the end of said midshaft adjacent saidshaft of said retrieving end acts as a stop preventing the midshaft frompenetrating the vaginal mucosa as said retrieving end is pushed upwardlytowards said suture.
 16. The surgical method of claim 15, wherein saidmidshaft and said shaft of said retrieving end are secured to oneanother in an angular relationship, and wherein said handle and saidmidshaft are secured to one another in an angular relationship.